A Biopsychosocial Approach to Improving Multidimensional Frailty Status in Community-Dwelling Older Adults

Not Applicable

Not yet recruiting

• Conditions: Frailty in Older Adults

• Registration Number: NCT06741878
• Lead Sponsor: Hong Kong Baptist University

Brief Summary

Frailty is a common clinical syndrome that is becoming increasingly important as populations age worldwide. Individuals who are frail are at a higher risk for negative outcomes, such as falls, disability, hospitalizations, and even death. The understanding of frailty has evolved from a straightforward concept to a complex model that includes physical, psychological, cognitive, and social factors. Since frailty is not static and can change over time, early interventions can be beneficial. Nevertheless, research in this area has been challenging due to a lack of agreement on what frailty encompasses and an inadequate understanding of how its different components interact. Defining frailty as a multidimensional issue is essential to recognize the adverse effects that can arise from medical, psychological, and social influences. However, recent studies have not sufficiently addressed how these different aspects work together or developed effective multidimensional interventions.

Detailed Description

The study will be designed as a four-arm, double-blinded, cluster-randomised controlled trial. A sample (N = 308) of prefrail older adults aged 60-80 years will be recruited from 32 randomly selected elderly community centres in Hong Kong and classified into four frailty deficit patterns (multi-frailty, physical-to-psycho/social, nonphysical-to-psycho/social, and a robust control). With the hypothesised biopsychosocial framework pinpointing the intertwined relationships of these three domains of frailty, four intervention strategies (biological/psychosocial/nutritional, biological/nutritional, psychosocial/nutritional, and an inactive control) will be proposed to improve their overall frailty, regarding their physical, psychological, and social functioning, nutritional status, and lifestyle changes in a 9-month intervention and follow-up period. The primary objective will be to assess the effectiveness of the intervention strategies for improving the frailty status of participants in each of the four frailty deficit pattern groups, and to determine the most effective intervention strategy.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-01-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• Age 60 to 80
• Willing and capable to participate in this study and training
• Willing and capable to give informed consent to participate in this study
• Preliminarily classified as physically prefrail/robust, in that they possess no more than three of the indicators on the Fried Frailty Index (FFI; unintentional weight loss, exhaustion, low physical activity, slow walking speed, weak grip strength; Bieniek et al., 2016)
• Can walk independently to an elderly centre
• Have a smartphone for internal group communication and remote interaction with their peers and the instructor

Exclusion Criteria

• History of systematic cardiovascular diseases causing stroke, Parkinson's disease, early stages of Alzheimer's disease, or cognitive impairment
• Physical injuries or other conditions that would hinder regular attendance and participation in the assessments for the study
• Concurrent major psychiatric disorder (e.g. major depressive disorder, schizophrenia) or drug and alcohol abuse
• Unable to handle digital devices
• Currently undergoing exercise programmes or classified as physically 'very active' (i.e. performing strenuous activity for 5+ hours each week)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Social Function (pre-test)	Pre-test (1st test): before intervention	The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
Frailty Status (pre-test)	Pre-test (1st test): before intervention	The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.
Frailty Status (2nd test)	2nd test: after 3-month intervention	The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.
Frailty Status (3rd test)	3rd test: after 6-month follow up	The Tilburg Frailty Indicator (TFI), with three subdomains (physical, psychological, and social), will be used in three evaluation time frames, respectively. The total TFI score ranges from 0 to 15, with a score of 5 (or above) indicating frailty.
Physical Functioning-- Anthropometic Data (pre-test)	Pre-test (1st test): before intervention	Anthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Anthropometric Data (2nd test)	2nd test: after 3-month intervention	Anthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Anthropometric Data (3rd test)	3rd test: after 6-month follow up	Anthropometric data (e.g. BMI in kg/m\^2) will be evaluated in 3 time frames, respectively.
Physical Functioning-- Health Related Information (pre-test)	Pre-test (1st test): before intervention	Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Health Related Information (2nd test)	2nd test: after 3-month intervention	Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Health Related Information (3rd test)	3rd test: after 6-month follow up	Health-related information (heart rate, daily step counts, etc.) collected by a Smart Band will be used in three evaluation time frames, respectively.
Physical Functioning-- Senior Physical Fitness Test Battery (pre-test)	Pre-test (1st test): before intervention	The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).
Psychological Functioning (3rd test)	3rd test: after 6-month follow up	A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.
Physical Functioning-- Senior Physical Fitness Test Battery (2nd test)	2nd test: after 3-month intervention	The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).
Physical Functioning-- Senior Physical Fitness Test Battery (3rd test)	3rd test: after 6-month follow up	The senior physical fitness test battery (SPFT) (Jones, 2013) will be used in three evaluation time frames, respectively. The SPFT consists of six physical tests for assessing functional fitness in the elderly: 30 sec arm curl (muscular strength), 30 sec chair stand (muscular strength), 2 min step test (aerobic endurance), chair sit-and-reach (flexibility), back scratch test (flexibility), and up-and-go (dynamic balance).
Psychological Functioning (pre-test)	Pre-test (1st test): before intervention	A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.
Psychological Functioning (2nd test)	2nd test: after 3-month intervention	A seven-item scale of psychological well-being, which is an indicator of psychological functioning in the Comprehensive Model of Frailty (CMF) (Kwan et al., 2015), will be used in three evaluation time frames, respectively.
Social Function (2nd test)	2nd test: after 3-month intervention	The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.
Social Function (3rd test)	3rd test: after 6-month follow up	The risk of social functioning deficits will be tested using the Social Frailty Index (SFI) in three evaluation time frames, respectively.

Secondary Outcome Measures

Name	Time	Method
Physical Activity Behavioural Changes (pre-test)	Pre-test (1st test): before intervention	Scales of physical activity behavioural change, intention/motivation, loneliness, subjective physical health, and health status will be measured using a survey that was used in a previous project (Chow et al., 2022), in three time frames.
Physical Activity Behavioural Changes (2nd test)	2nd test: after 3-month intervention	Scales of physical activity behavioural change, intention/motivation, loneliness, subjective physical health, and health status will be measured using a survey that was used in a previous project (Chow et al., 2022), in three time frames.
Physical Activity Behavioural Changes (3rd test)	3rd test: after 6-month follow up	Scales of physical activity behavioural change, intention/motivation, loneliness, subjective physical health, and health status will be measured using a survey that was used in a previous project (Chow et al., 2022), in three time frames.
Exercise Self-efficacy (pre-test)	Pre-test (1st test): before intervention	Assessed using the validated Chinese scales of the Physical Exercise Self-efficacy Scale (PESES), a 5-item instrument with a 4-point Likert-type scale, ranging from 5 to 20. Higher scores shows higher routine physical exercise self-efficacy.
Exercise Self-efficacy (2nd test)	2nd test: after 3-month intervention	Assessed using the validated Chinese scales of the Physical Exercise Self-efficacy Scale (PESES), a 5-item instrument with a 4-point Likert-type scale, ranging from 5 to 20. Higher scores shows higher routine physical exercise self-efficacy.
Exercise Self-efficacy (3rd test)	3rd test: after 6-month follow up	Assessed using the validated Chinese scales of the Physical Exercise Self-efficacy Scale (PESES), a 5-item instrument with a 4-point Likert-type scale, ranging from 5 to 20. Higher scores shows higher routine physical exercise self-efficacy.
Nutrition Self-efficacy (pre-test)	Pre-test (1st test): before intervention	Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Nutrition Self-efficacy (2nd test)	2nd test: after 3-month intervention	Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Nutrition Self-efficacy (3rd test)	3rd test: after 6-month follow up	Assessed using the Nutrition Self-efficacy Scale (NSES) (Schwarzer, 2009; Wong et al., 2020).
Nutritional Status (pre-test)	Pre-test (1st test): before intervention	Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Nutritional Status (2nd test)	2nd test: after 3-month intervention	Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.
Nutritional Status (3rd test)	3rd test: after 6-month follow up	Assessed by the Mini Nutritional Assessment scale (MNA). The MNA score ranges from 0 to 14, with a higher score indicating better nutritional status.